A Study of RO5028442 in Adult Male High-Functioning Autistic Patients

Status:	Completed
Conditions:	Neurology, Psychiatric
Therapuetic Areas:	Neurology, Psychiatry / Psychology
Healthy:	No
Age Range:	18 - 45
Updated:	8/3/2016
Start Date:	December 2011
End Date:	March 2013

A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients

This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and
the safety and tolerability of a single dose of RO5028442 in adult male high-functioning
autistic patients. In a cross-over design, patients will be randomized to receive either a
single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated
time on study is up to approximately 9 weeks.

Inclusion Criteria:

- Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the
team and supported with the Autistic Diagnostic Observation Schedule (ADOS)

- Male adults, 18 to 45 years of age

- IQ > 70 (Wechsler Adult Intelligence Scale-Full scale)

- Body mass index (BMI) 18 to 35 kg/m2 inclusive

- Aberrant Behavior Checklist (ABC) - Irritability subscale score
Exclusion Criteria:

- Positive urine test for drugs of abuse

- Alcohol and/or substance abuse/dependence during the last 12 months

- Positive for hepatitis B, hepatitis C or HIV infection

- Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder

- Active inflammatory pulmonary disease

- History of epilepsy/seizure disorder (except for simple febrile seizures)

- Initiation of new or major change in psychosocial intervention within 4 weeks prior
to randomization

- Treatment with any investigational agent within 90 days prior to screening

- History of hypersensitivity or allergic reactions

We found this trial at

sites

Clinical Trial Facility in Bronx New York

Bronx, New York

from

Bronx, NY